Bortezomib (Velcade) With Standard Chemotherapy for Relapsed or Refractory Follicular Lymphoma

NCT ID: NCT00510887

Last Updated: 2014-05-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2013-09-30

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of combining bortezomib (Velcade) with rituximab, fludarabine, mitoxantrone, and dexamethasone in treating patients with follicular cell lymphoma.

Detailed Description

This is a phase II study using the combination of bortezomib, rituximab, fludarabine, mitoxantrone and dexamethasone. The combination will given over a 28 day cycle. In addition each patient will receive Pneumocystis carinii Pneumonia (PCP) prophylaxis with Trimethoprim/sulfamethoxazole (TMP/Sulfa) or equivalent agent. On day 4 the physician has the option of starting granulocyte colony-stimulating factor (GCSF), granulocyte macrophage colony-stimulating factor (GMCSF), or pegylated GCSF.

All patients who receive at least one dose of the drug will be evaluated for toxicity. Patients will be treated with the agent for at least 2 cycles to be considered eligible for evaluation of response. The chemotherapy dosing will continue until there is evidence of disease progression, a second recurrence of unacceptable toxicity, or a maximum of 8 courses of therapy.

Conditions

Lymphoma, Follicular

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VR-FND

Bortezomib (VELCADER) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.

Each cycle will be repeated every 28 days for 8 cycles maximum.

Group Type: EXPERIMENTAL

Bortezomib

Intervention Type: DRUG

Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle

Rituximab

Intervention Type: DRUG

Rituximab 375 mg/m2 IV on day 1

Fludarabine

Intervention Type: DRUG

Fludarabine 25 mg/m2 IV on days 1,2,3

Mitoxantrone

Intervention Type: DRUG

Mitoxantrone 10 mg/m2 IV on day 2

Dexamethasone

Intervention Type: DRUG

Dexamethasone 20 mg orally on days 1,2,3,4,5

Interventions

Bortezomib

Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle

Intervention Type: DRUG

Rituximab

Rituximab 375 mg/m2 IV on day 1

Intervention Type: DRUG

Fludarabine

Fludarabine 25 mg/m2 IV on days 1,2,3

Intervention Type: DRUG

Mitoxantrone

Mitoxantrone 10 mg/m2 IV on day 2

Intervention Type: DRUG

Dexamethasone

Dexamethasone 20 mg orally on days 1,2,3,4,5

Intervention Type: DRUG

Other Intervention Names

Velcade; Novantrone

Eligibility Criteria

Inclusion Criteria

• Diagnosis of grade 1-3 follicular lymphoma with persistent, relapsed, or refractory disease to at least one prior regimen.
• No prior bortezomib therapy.
• Voluntary written informed consent.
• Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control.
• Male subject agrees to use an acceptable method for contraception for the duration of the study therapy.
• 18 years of age or older.
• aspartate aminotransferase (AST),alanine aminotransferase (ALT), total bilirubin < 3 times the upper limit of normal unless documented by the treating physician to be secondary to underlying lymphoma.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Exclusion Criteria

• Platelet count of < 50,000 within 14 days before enrollment unless documented by the treating physician to be due to the disease.
• Absolute neutrophil count of < 1000 within 14 days before enrollment unless documented by the treating physician to be due to disease.
• Estimated or measured creatinine clearance of less than 30 ml/min within 14 days before enrollment.
• ≥Grade 2 peripheral neuropathy within 14 days before enrollment.
• Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia.
• Patient has hypersensitivity to boron, mannitol or any drug included in the current protocol.
• Female subject is pregnant or lactating.
• Received other investigational drugs for this disease within 14 days of enrollment
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
• Known HIV+ status.
• Cardiac ejection fraction less than 35% at study entry measured by echocardiogram, Multigated Acquisition (MUGA) or cardiac MRI.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David A Rizzieri, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

8785

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00008487

Identifier Type: -

Identifier Source: org_study_id